NuEra Tight RF Model OptiStream— 510(k) K230755

Substantially Equivalent

Bios S.R.L.

FDA 510(k) clearance K230755 for NuEra Tight RF Model OptiStream, Substantially Equivalent on 2023-10-30. Applicant: Bios S.R.L.. Device class: 2.

Clearance details

Applicant: Bios S.R.L.
Product code: Code PBX
Device class: Class 2
Regulation: 21 CFR 878.4400
Advisory panel: General, Plastic Surgery
Date received: 2023-03-17
Decision date: 2023-10-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vimodrone, IT

Download summary PDF View on FDA.gov ↗

Recent devices under product code PBX

K253480 — Capenergy C Equipments RF C200 and C400 Drakarian2026-07-10
K260647 — SPECCHIO2026-04-02
K253261 — Apollo Quattro (APQ-10M)2026-03-13
K252888 — NeoSculpt Plus2026-03-09
K250734 — OptiLUV Device2025-09-10

More clearances from Bios S.R.L.

K243445 — Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)2024-12-30
K241407 — Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)2024-06-14
K223856 — NuEra Tight RF Family2023-08-11
K223907 — NuEra Tight RF Model APMD145.M70-US2023-05-02
K210867 — NuEra Tight RF, NuEra Tight RF Plus2021-04-21

Data sourced from openFDA. This site is unofficial and independent of the FDA.